Method for Screening Lyophilized Parenteral Formulations

摘要

Embodiments of the present invention feature methods for screening parenteral formulations which require small quantities of drug and rapid results. The method features steps of identifying one or more solutions for reconstitution and applying the solutions to lyophilized drug, excipient and diluent combinations.

主权项

1. A method for identifying one or more solutions for rehydration, excipients and diluents for use with a compound of interest in a lyophilization process and rehydration process, for parenteral formulations with such compound of interest, said method comprising the steps of:
a. providing a plurality of wells for performing lyophilization processes, said plurality of wells divided into well groups, said well groups corresponding to at least a first well group and at least one second well group, said first well group having at least one well for receiving each test rehydrating solution, said second well group having at least one well for receiving a quantity of a test excipient and/or diluent; b. placing an aliquot of a compound of interest to each well of said first well group and said second well group, said aliquot having a concentration of the compound of interest at or above the desired concentration of a parenteral formulation, and placing a quantity of a test excipient and/or diluent to each wells of said second well group, and placing the contents of all wells of the first well group and the second well group in solution; c. imposing lyophilization conditions on said plurality of wells to produce a plurality of lyophilized samples comprising lyophilized compound of interest in each well of said first well group, and lyophilized compound of interest with a test excipient and/or diluent in each well of said second well group; d. rehydrating a well of said first well group with each test rehydrating solution and identifying at least one preferred rehydrating solution; and e. rehydrating each well of said second group of wells with said at least one preferred rehydrating solution to identify at least one preferred rehydrating solution and at least one preferred excipient and/or diluent for use with a parenteral formulation of the compound of interest.